Essentials of European Medical Device Regulatory Affairs

Classification of medical devices Significant changes in the MDR

Devices with ancillary medicinal substances MDR Annex VIII (Rule 14)

• All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, with action ancillary to that of the devices, are in class III.

• “liablity to act” wording has been removed from MDD Rule 13 definition

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Classification of medical devices Significant changes in the MDR

Non-Viable Human Tissues MDR Annex VIII (Rule 18)

• All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable are in class III , unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non- viable that are intended to come into contact with intact skin only

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